E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma

NCT ID: NCT01271504

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-19
• Study Completion Date: 2015-06-23

Brief Summary

The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.

Detailed Description

This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with sorafenib; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with hepatocellular carcinoma will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. In both Phase Ib and phase II, Patients will receive study treatment (E7050 plus sorafenib or sorafenib alone) until the occurrence of progressive disease (PD)for approximately six 28-day cycles (24 weeks). After 6 cycles. ath the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050, with or without sorafenib (Arm 1), or may continue sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Patients will be followed until death following completion of therapy.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase Ib: Cohort 1,2, and 3

Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib

Phase II: Arm 1; E7050 + Sorafenib

Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

E7050 given orally at 200, 300 or 400 mg once daily.

Sorafenib given orally, 400 mg twice daily.

Interventions

Sorafenib

Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib

Intervention Type: DRUG

Sorafenib

E7050 given orally at 200, 300 or 400 mg once daily.

Sorafenib given orally, 400 mg twice daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Unresectable locally advanced or metastatic HCC;
• Histologic confirmation not required if other diagnostic criteria are met;
• No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
• ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
• Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;

Exclusion Criteria

• Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
• Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
• Palliative radiotherapy is not permitted throughout the study period;
• Active hemoptysis
• Serious non-healing wound, ulcer, or active bone fracture;
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
• Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (TIPS) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaBio Development Inc.

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa J Versola, RN

Role: STUDY_DIRECTOR

Quintiles, Inc.

Locations

Tucson, Arizona, United States

Fort Myers, Florida, United States

St. Petersburg, Florida, United States

Chapel Hill, North Carolina, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Nashville, Tennessee, United States

Brussels, , Belgium

Brussels, , Belgium

Leuven, , Belgium

Rozzano, Milano, Italy

Modena, , Italy

Pavia, , Italy

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Dnipropetrovsk, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Lviv, , Ukraine

London, Greater London, United Kingdom

Manchester, Greater Manchester, United Kingdom

Glasgow, Strathclyde, United Kingdom

Countries

United States; Belgium; Italy; Spain; Ukraine; United Kingdom

Other Identifiers

2011-000752-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7050-701

Identifier Type: -

Identifier Source: org_study_id